Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K002143 |
Device Name |
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM |
Applicant |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Applicant Contact |
SUSAN SILAVIN, PH.D. |
Correspondent |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Correspondent Contact |
SUSAN SILAVIN, PH.D. |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 07/17/2000 |
Decision Date | 10/12/2000 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|